Medline Medical Procedure Kits With Plastic Syringes Recalled for Quality Issues
Medline medical procedure kits containing plastic syringes are being recalled due to identified leaks, breakage, and quality issues that may pose a risk to patient health.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: These medical procedure kits contain identified quality defects (leaks, breakage) affecting critical surgical supplies, fitting the 'risk-of-harm products where injury has not yet been reported' criterion. No illnesses or injuries have been reported in the source.
Plain-English summary
Medline Industries is recalling multiple medical procedure kits that contain plastic syringes. The affected products include LSGyn Pack, Main Cysto, OB Pack-LF, Pelviscopy Pack-LF, Posterior Eye Pack-LF, and Robotics Pack-LF, with a total of 570 units involved. These kits are distributed worldwide, including throughout the United States and Canada.
The syringes in these kits are affected by an FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and other quality issues have been identified in the plastic syringes that may pose a risk to patient health.
Healthcare facilities and users who have received these kits should identify them by pack number and lot number and contact Medline Industries for instructions on returns or replacement.
The recalled product
- Product
- Medline procedure kits labeled as: 1) L S GYN PACK, Pack Number DYNJ65616C; 2) MAIN CYSTO, Pack Number DYNJ61371A; 3) OB PACK-LF, Pack Number DYNJ20720C; 4) PELVISCOPY PACK-LF, Pack Number DYNJ0415776N; 5) POSTERIOR EYE PACK-LF, Pack Number PHS656483I; 6) ROBOTICS…
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Affected units
- 570
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (12)
- 1) Pack Number DYNJ65616C: UDI/DI 10195327470869 (each) 40195327470860 (case)
- Lot Number 23LMF217A
- 2) Pack Number DYNJ61371A: UDI/DI 10193489796803 (each) 40193489796804 (case)
- Lot Number 21FMA140A
- 3) Pack Number DYNJ20720C: UDI/DI 10884389620564 (each) 40884389620565 (case)
- Lot Number 21EMF438A
- 4) Pack Number DYNJ0415776N: UDI/DI 10193489413984 (each) 40193489413985 (case)
- Lot Number 22CMD073A
- 5) Pack Number PHS656483I: UDI/DI 10889942806768 (each) 40889942806769 (case)
- Lot Number 23GMB728A
- 6) Pack Number DYNJ0046667A: UDI/DI 10889942160396 (each) 40889942160397 (case)
- Lot Number 22CMD979A
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 19 recalled by MEDLINE INDUSTRIES, LP - Northfield under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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